Using closed-loop spinal cord stimulation to manage spasticity after stroke

Closed Loop Spinal Cord Stimulation (SCS) for Neuromodulation of UMN-Lesion Spasticity

This study is testing if a new spinal cord stimulation method can help people who have had a stroke manage muscle tightness and chronic pain.

Quick facts

• Study type: Observational
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06384170 on ClinicalTrials.gov

What this trial studies

This observational study investigates the use of closed-loop spinal cord stimulation (SCS) to manage spasticity and chronic pain in patients who have experienced a first-ever stroke. The approach focuses on neuromodulation to alleviate symptoms associated with upper motor neuron lesions, which can lead to increased muscle tension and resistance to movement. Eligible participants will be those aged 18 and older who have been experiencing neuropathic pain for more than three months post-stroke. The study aims to gather data on the effectiveness of this innovative treatment method in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have had a first-ever stroke and are experiencing chronic neuropathic pain and spasticity for more than three months.

Not a fit: Patients with mild or non-debilitating pain, or those who have previously undergone spinal cord stimulation, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce spasticity and improve quality of life for stroke survivors experiencing chronic pain.

How similar studies have performed: While the use of spinal cord stimulation is established, the closed-loop approach is relatively novel and has not been extensively tested in this specific context.

Eligibility criteria

Inclusion Criteria:

1. First-ever stroke
2. Aged 18 and older
3. Neuropathic pain \>3 months (chronic)
4. Brain injury associated with spasticity in one or multiple limbs \>3 months post-stroke
5. No previous history of neuropathic pain or spasticity in affected limbs
6. Cognitively capable to operate the SCS system

Exclusion Criteria:

1. Inadequate Pain Severity: Patients with mild or non-debilitating pain may be excluded if the treatment is intended for individuals with moderate to severe pain.
2. Previous SCS Implantation: Patients who have previously undergone SCS implantation may be excluded to focus on those who are new to the therapy.
3. Inadequate Pain Duration: Some trials may exclude patients whose pain has not persisted for a minimum period to ensure that the pain condition is chronic.
4. Medical Comorbidities: Patients with certain medical conditions or comorbidities that may increase the risks associated with SCS, such as uncontrolled cardiovascular disease, uncontrolled diabetes, or active infections, may be excluded.
5. Psychological Factors: Patients with severe psychiatric disorders or psychological conditions that may interfere with the assessment of pain or the ability to provide informed consent may be excluded.
6. Allergies or Sensitivities: Patients with allergies to materials used in SCS devices or contraindications to the anesthesia used during implantation may be excluded.
7. Substance Abuse: Patients with active substance abuse or addiction issues may be excluded due to concerns about treatment compliance and efficacy.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Akhil Chhatre, MD — Johns Hopkins University
• Study coordinator: Harman Chopra, MD

Conditions Chronic Pain; Spasticity as Sequela of Stroke; Upper Motor Neuron Lesion; Spinal Cord Stimulation; Neuromodulation; Closed-loop SCS; Post-Stroke Pain; Spasticity